Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus

What Was Tested

The trial (not phased) is built around Liraglutide.

More and more patients who need surgery have diabetes mellitus type II.

Despite an enormous amount of glucose lowering protocols and the proven negative effects of hyperglycaemia.

It had three arms (groups): BR (bolus regimen) (experimental), LG (Liraglutide) (experimental) and GIK (glucose -insulin - potassium) infusion (active comparator).

The registry classes the interventions as drug.

More on the Plan

Multiple protocols for perioperative glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium infusion to subcutaneous bolus regimens.

Despite this abundance of published glucose lowering protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there is no evidence regarding the optimal intraoperative glucose lowering treatment.

Recently, incretins have been introduced to lower blood glucose.

The main hormone of the incretin system is glucagon-like peptide-1 (GLP-1).

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent. Known diabetes mellitus type II for \> 3 months. Aged 18-75 years. Scheduled for elective non-cardiac surgery.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: oral corticosteroid use; planned for day-care (ambulant) surgery; planned icu stay post-operatively.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-01 with completion listed for 2017-01.

It ran at 3 sites in Netherlands (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Median glucose (time frame: 1 hour after surgery).

It also tracked 6 secondary outcomes, for example Total Insulin administration, Median glucose, Postoperative complications, Hypoglycemia, Hypo- and hyperkalemia and Glucose.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 150 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.